MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE; PISTON SYRINGE

Model Number 328521

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: customer returned (1) loose 0.3ml insulin syringe.Consumer reported found 1 syringe without a needle when remove shield.The returned syringe was examined, and it was observed that the needle hub/shield assembly was detached.No damage to the barrel tip was observed.Manufacturing ((b)(4)) will be notified of the observed issue.A review of the device history record was completed for batch #0335581.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that did not pertain to the complaint.Based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (hub separates).Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Capa# (b)(4) has been opened to address this issue.

Event Description

It was reported that the needle hub had detached from the relion® insulin syringe.The following information was provided by the initial reporter: "consumer reported found 1 syringe without a needle when remove shield".Via bd investigation: "the returned syringe was examined, and it was observed that the needle hub/shield assembly was detached.".

• Brand Name: RELION INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12238487
• MDR Text Key: 263857535
• Report Number: 1920898-2021-00822
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138383
• UDI-Public: 00681131138383
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328521
• Device Catalogue Number: 328521
• Device Lot Number: 0335581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1